Celltrion and Teva’s Rituximab Biosimilar Gains FDA Approval
The FDA announced the first biosimilar of Roche’s blockbuster cancer drug Rituxan (rituximab) — approving Teva and Celltrion’s Truxima (rituximab-abbs) for treating non-Hodgkin’s lymphoma.
The 15th biosimilar to be cleared by the FDA, Truxima is approved for treating adult patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent;
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first- line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as a single-agent maintenance therapy; and
- Non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.
“We’re seeing more biosimilar drugs gain market share as this industry matures,” Commissioner Scott Gottlieb said in announcing the approval.